연봉 ₩30,000,000 - ₩50,000,000 per annum
컨설턴트 Jessie Jin
채용 공고일 2018년 6월 22일 (금)26 Euljiro 5 gil Jung-gu Seoul 04539 Robert Walters
An international medical device manufacturer is in need of an RA/QA Specialist with bilingual proficiency in English and Korean. In this role you will develop an understanding of regulatory requirements and medical device regulations and work to ensure compliance.
- Manage the product registration process and coordinate activities related to the submission and approval of products to government regulatory agencies
- Lead all procedures of product registration and administrative work accurately and efficiently
- Ensure adherence to standard operating procedures and protocol for the rapid and timely approval of new medical devices and regulatory support of marketed products
- Support the RA/QA Manager in handling customer complaints and preparing internal and external audits
- Represent the company and participate in government and industry meetings
- Bachelor’s degree in a discipline related to science, engineering, or medicine
- RA/QA experience in the medical device industry preferred
- Experience working in cross-functional environments
- Ability to review and translate technical documentation into effective regulatory submissions
- Advanced verbal and written proficiency in both English and Korean
About the Company:
A global technology leader in the medical industry with over 20 years of history. This company mainly produces medical devices to assist surgery with minimal invasion and is rapidly growing in the Korean market.